Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The incidence of hypoxia
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique for evaluating the bile duct, pancreatic duct, and ampulla. Hypoxia is the most common cardiopulmonary complication during ERCP, with a reported rate of 16.2 to 39.2%. The key to preventing hypoxia is to ensure the sufficient oxygenation and ventilation of patients during these procedures. The commonly used approaches to treat hypoxia with a non-instrumented airway are increasing the oxygen flow and lifting the jaw, applying with both hands, displacing the jaw upwards and anteriorly, which allowed the upper airway to remain open. We hypothesized that the supraglottic oxygen delivery via an endotracheal tube can reduce the incidence of hypoxia in patients under deep sedation during ERCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years；
- •The ASA classification ranges from I to III.
- •Patients have signed the informed consent form.
- •Patients scheduled to undergo sedated ERCP examination;
- •The estimated duration of the procedure does not exceed 45 minutes.
排除标准
- •Severe cardiac dysfunction (<4 METs);
- •Severe renal insufficiency (requiring preoperative dialysis);
- •Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
- •Increased intracranial pressure;
- •Upper respiratory tract infections (oral/nasal/pharyngeal);
- •Fever (core temperature >37.5°C);
- •Confirmed pregnancy or current breastfeeding;
- •Allergy to sedatives (e.g., propofol) or medical adhesives;
- •BMI >30 kg/m²;
- •Current participation in other clinical trials;
结局指标
主要结局
The incidence of hypoxia
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 \< 90% for \<60 s
次要结局
- The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- The incidence of severe hypoxia(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Chair of the Department of Anesthesiology
Zhejiang University